After study enrollment, all subjects started anakinra (Kineret™; Amgen, Thousand Oaks, CA, USA) as a subcutaneous daily injection. Subjects weighing >25 kg at the time of enrollment received 100 mg daily, whereas those weighing <25 kg received 50 mg daily. Anakinra was continued for 28 d with no dose adjustment.

Patients at Children's Medical Center Dallas between ages 6 and 18 years with Type 1 diabetes within one week of diagnosis were eligible.
Diabetes care. At diagnosis, all subjects were placed on a basal-bolus insulin regimen with glargine and either lispro or aspart. For the duration of the study, insulin doses were adjusted per standard clinic protocol with target glucose of 80-140 mg/dL fasting and 80-180 mg/dL before meals. At each study visit, we recorded the subject's current insulin doses and weight to allow calculation of the total daily dose (units/kg/day).
Anakinra. After study enrollment, all subjects started anakinra (Kineret; Amgen, Thousand Oaks, CA) as a subcutaneous daily injection. Subjects weighing more than 25 kg at the time of enrollment received 100 mg daily whereas those weighing 25 kg or less received 50 mg daily. Anakinra was continued for a total of 28 days with no dose adjustment.

Anakinra

Sex: Female, Male

Ethnicity (NIH/OMB)

A1c (Median (IQR))

Beta hydroxybutyrate (mg/dL) (Median (IQR))

Total daily insulin dose at hospital discharge (U/kg/day) (Mean)

Initial IDAA1c (Median (IQR))

Expression data at baseline and after treatment were available on 10 patients who had received anakinra. These were compared to similarly-timed samples from 10 patients from control group B. Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed.

12 autoantibody positive subjects with newly diagnosed type 1 diabetes who were treated with anakinra

Effect of Anakinra Treatment on PBMC Gene Expression for Patients

Mixed-meal tolerance tests. MMTTs were conducted at the UT Southwestern Clinical Translational Research Center (CTRC). Subjects underwent MMTTs at 3-4 wk after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed by Dr Philip Raskin (UTSouthwestern MedicalCenter, Dallas, TX,USA). C-peptide AUC was calculated for each MMTT using the trapezoidal method. C-peptide AUC data between groups were rank transformed and then analyzed using a two-way repeated measures analysis of variance (ANOVA).

C-peptide Secretory Capacity

Patients at Children's Medical Center Dallas between ages 6 and 18 yr with type 1 diabetes within 1 wk of diagnosis were eligible. Exclusion criteria included treatment with systemic or inhaled corticosteroids or any other immunomodulatory drug, active infection, history of mycobacterial disease, pregnancy, live vaccine administration within 90 d of enrollment, and severe comorbidities. Patients were excluded if it was uncertain whether they had type 1 or type 2 diabetes.

Overall Study

Perrin White

Type 1 Diabetes Mellitus

Patients will receive daily anakinra therapy for 28 days

Children's Medical Center

Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes

An Exploratory, Open Label Study of Anti-inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type 1 Diabetes Mellitus

University of Texas Southwestern Medical Center

Children's Medical Center Dallas

Recombinant human intranasal insulin formulation in a buffered solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product is formulated at a dose strength of 1100 IU / mL (40mg/mL) manufacturing formulation. The product will be self administered by eligible participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Placebo insulin carrier solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product will be self administered by participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Type 1 Diabetes

Intranasal insulin

Placebo insulin carrier solution containing benzalkonium chloride and glycerol

Placebo

The Children's Hospital at Westmead

Mater Children's Hospital

Womens and Childrens Hospital

Royal Melbourne Hospital

Princess Margaret Hospital

University of Auckland

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

A Randomised, Double-blind, Placebo-controlled Trial of Intranasal Insulin (440 IU) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II

Defined as the presence of 2 or more of the following diagnostic criteria including diabetic fasting blood glucose level, diabetic 2 hour postprandial blood glucose level, diabetic HbA1c and symptoms

Measured as glucose and insulin responses in Oral glucose tolerance test (OGTT) 6 monthly

Insulin resistance measured by Homeostasis of model assessment - resistance (HOMA-R) 6 monthly

Measured by levels of circulating antibodies to insulin, Glutamic acid decarboxylase (GAD) and Tyrosine phosphatase - like insulinoma antigen (IA-2) and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years

insulinoma/phosphatase

Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

Найповніша база даних про лікарські трави, підкріплена наукою